Flexbumin Special Precautions

human albumin




Zuellig Pharma
Full Prescribing Info
Special Precautions
Hemodynamics: Do not administer FLEXBUMIN without very close monitoring of hemodynamics, look for evidence of cardiac or respiratory failure, renal failure, or increasing intra-cranial pressure.
Hypervolemia/Hemodilution: FLEXBUMIN should be used with caution in conditions where hypervolemia and its consequences or hemodilution could represent a special risk for the patient. Examples may include but are not limited to: Decompensated cardiac insufficiency, hypertension, esophageal varices, pulmonary edema, hemorrhagic diathesis, severe anemia, renal and post-renal failure.
The rate of administration should be adjusted according to the solution concentration and the patient's hemodynamic measurements. Rapid administration might cause circulatory overload and pulmonary edema. At the first clinical signs of cardiovascular overload (headache, dyspnea, jugular vein congestion), or increased blood pressure, raised central venous pressure and pulmonary edema, the infusion is to be stopped immediately.
Large Volumes: If comparatively large volumes are to be replaced, controls of coagulation and hematocrit are necessary. Care must be taken to ensure adequate substitution of other blood constituents (coagulation factors, electrolytes, platelets, and erythrocytes). Appropriate hemodynamic monitoring should be undertaken.
Electrolyte Status: When FLEXBUMIN is given, the electrolyte status of the patient should be monitored and appropriate steps taken to restore or maintain the electrolyte balance. FLEXBUMIN solutions contain 130-160 mmol/l sodium. The amount of sodium in FLEXBUMIN is to be taken into consideration for patients on a controlled sodium diet.
Blood pressure: A rise in blood pressure after FLEXBUMIN infusion necessitates careful observation of the injured or post-operative patient in order to detect and treat severed blood vessels that may not have bled at a lower blood pressure.
Effects on the Ability to Drive and Operate Machines: There is no information of the effects of FLEXBUMIN on the ability to drive or operate an automobile or other heavy machinery.
Use in Children: The safety and efficacy of the use of FLEXBUMIN solution in pediatric patients have not been established in clinical trials; however, the use of albumin solutions in the pediatric population is referenced in the medical literature.
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